Japanese Study of Rimonabant in Obese Patients With Dyslipidemia (VENUS)

Obesity Clinical Trial

Official title:

A Randomized Double-blind, Placebo-controlled, Parallel-group, Fixed Single-dose Regimen (SR141716 20 mg), Multicenter Study to Assess the Efficacy and Safety of SR141716 in Obese Patients With Dyslipidemia.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00434096
• Other study ID #: EFC5749
• Status: Terminated
• Phase: Phase 3
• First received: February 9, 2007
• Last updated: July 17, 2009
• Start date: February 2007
• Est. completion date: February 2009

Study information

• Verified date: July 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to assess the efficacy of SR141716 compared to placebo on body weight and triglycerides changes over a period of 52 weeks.

Secondary objectives are:

• To evaluate the effect of SR141716 compared to placebo over a period of 52 weeks, on HDL-cholesterol and visceral fat area.

• To evaluate the safety of SR141716 compared to placebo over a period of 104 weeks.

• To evaluate the pharmacokinetics of SR141716.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 915
• Est. completion date: February 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI) > 25 kg/m²

• Visceral Fat Area (VFA) > 100 cm²

• Triglycerides (TG) > 150 mg/dL and < 700 mg/dL, and/or HDL-cholesterol < 40 mg/dL(Dyslipidemia)

• At least 1 criteria of the following 2 comorbidities:

• Impaired Glucose Tolerance or Type 2 diabetes

• Hypertension

Exclusion Criteria:

• Patient with a secondary obesity.

• Patients who have received the diet therapy for less than 8 weeks before start of the observation period.

• Patients whose body weight changed by more than the variation of ± 2kg for screening period.

• Low compliance to drug intake (< 80%) and dietary instruction during the observation period.

• Patients with type 1 diabetes.

• Patients with a primary hyperlipidemia (i.e., familial hypercholesterolemia, familial combined hyperlipidemia and familial type III hyperlipidemia).

• Patients with a LDL-cholesterol > 190 mg/dL at any of Weeks -8 or -4.

• Patients with a secondary hypertension.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dyslipidemias
• Obesity

Intervention

Drug:
• rimonabant (SR141716)
oral administration once daily
• placebo
oral administration once daily

Locations

Country	Name	City	State
Japan	Sanofi-Aventis Administrative Office	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight: relative change from baseline		Week 52	No
Primary	triglycerides: relative change from baseline		Week 52	No
Secondary	HDL-cholesterol ;visceral fat area		Week 52	No
Secondary	Safety: Adverse events		study period	Yes